Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DHA · Predicate Candidate Screening
72 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
255 days90th percentile
72clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | Ortho Clinical Diagnostics | 2024-05-08 | 183 | 0 |
| K223690 | iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: i | Shenzhen Yhlo Biotech Co., Ltd. | 2023-12-11 | 367 | 0 |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Abbott Laboratories | 2023-06-05 | 63 | 0 |
| K230790 | Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent | Abbott Laboratories | 2023-05-19 | 58 | 0 |
| K221990 | Access Total ßhCG (5th IS) | Beckman Coulter, Inc. | 2022-12-27 | 174 | 0 |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite | Diazyme Laboratories, Inc. | 2021-12-13 | 150 | 0 |
| K203227 | Elecsys HCG STAT | Roche Diagnostics | 2021-08-18 | 289 | 0 |
| K200210 | ADVIA Centaur® Total hCG assay | Siemens Healthcare Diagnostics, Inc. | 2021-07-13 | 532 | 0 |
| K192547 | MAGLUMI 2000 HCG/ß-HCG | Shenzhen New Industries Biomedical Engineering Co., Ltd. | 2020-01-17 | 122 | 0 |
| K192790 | Atellica IM Total hCG (ThCG) | Siemens Healthcare Diagnostics, Inc. | 2019-10-30 | 30 | 0 |
| K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System | Abbott Laboratories | 2017-10-23 | 264 | 2 |
| K163418 | Diazyme DZ-Lite Total beta-hCG Test System | Diazyme Laboratories | 2017-08-18 | 255 | 0 |
| K133002 | i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, | Abbott Point of Care, Inc. | 2015-04-16 | 569 | 0 |
| K130020 | ACCESS TOTAL BHCG (5TH IS) | Beckman Coulter, Inc. | 2013-10-01 | 271 | 0 |
| K131037 | LIAISON XL HCG | DiaSorin, Inc. | 2013-09-06 | 144 | 0 |
| K072500 | ONE STEP HCG URINE/SERUM TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2009-04-21 | 594 | 0 |
| K080094 | OLYMPUS TOTAL BHCG TEST SYSTEN | Olympus Life Science Research Europa GmbH (Europa) | 2008-09-03 | 233 | 0 |
| K063720 | VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK | Ortho-Clinical Diagnostics | 2007-04-09 | 115 | 0 |
| K063754 | DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHC | Dade Behring, Inc. | 2007-02-23 | 66 | 0 |
| K060548 | STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TEST | Dade Behring, Inc. | 2006-04-06 | 36 | 2 |
| K042676 | NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTR | Nichols Institute Diagnostics | 2004-12-17 | 79 | 1 |
| K033234 | IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER | Diagnostic Products Corp. | 2003-12-12 | 67 | 3 |
| K031052 | CARESTART HCG ONE-STEP PREGNANCY TEST | Access Bio Incorporate | 2003-06-13 | 72 | 0 |
| K022680 | AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK | Azog, Inc. | 2002-11-01 | 81 | 0 |
| K022681 | AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASS | Azog, Inc. | 2002-11-01 | 81 | 0 |
| K013857 | AIMSTEP PREGNANCY | Germaine Laboratories, Inc. | 2002-01-22 | 62 | 0 |
| K013678 | VICTORCH MEDITEK'S HCG TEST CARD | Victorch Meditek, Inc. | 2001-12-27 | 50 | 0 |
| K003696 | STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYST | Dade Behring, Inc. | 2001-01-25 | 56 | 2 |
| K003178 | ELECSYS HCG AND BETA TEST SYSTEM | Roche Diagnostics Corp. | 2000-12-14 | 64 | 0 |
| K002148 | ELECSYS HCG TEST SYSTEM | Roche Diagnostics Corp. | 2000-08-22 | 36 | 0 |
| K000844 | ABSOLUTE HCG PREGNANCY TEST | Mizuho USA, Inc. | 2000-06-16 | 93 | 0 |
| K994085 | IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 | Diagnostic Products Corp. | 2000-01-28 | 56 | 0 |
| K991532 | DRX QT. HCG | Metrika, Inc. | 1999-09-17 | 137 | 0 |
| K991515 | INSURE PREGNANCY TEST | Inbios Intl., Inc. | 1999-05-28 | 28 | 0 |
| K990222 | IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L | Diagnostic Products Corp. | 1999-02-26 | 32 | 0 |
| K983424 | ABBOTT ARCHEITECT TOTAL B-HCG | Abbott Laboratories | 1998-12-01 | 63 | 0 |
| K974368 | AIMSTICK PBD PREGNANCY | Germaine Laboratories, Inc. | 1998-01-02 | 43 | 0 |
| K974512 | AIMSTICK PBD COMBO PREGNANCY | Germaine Laboratories, Inc. | 1998-01-02 | 32 | 0 |
| K974425 | BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP P | Princeton BioMeditech Corp. | 1997-12-24 | 30 | 0 |
| K973825 | MIDSTREAM HOME REGNANCY TEST | Germaine Laboratories, Inc. | 1997-12-19 | 73 | 0 |
| K970894 | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK ( | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-04-14 | 34 | 0 |
| K970387 | HUMAN CHORIONIC GONADOTROPIN METHOD | Dade Chemistry Systems, Inc. | 1997-03-10 | 35 | 0 |
| K961792 | BIOCIRCUITS IOS SERUM PREGNANCY TEST CARTRIDGES/IMMUNOASSAY | Biocircuits Corp. | 1996-08-21 | 104 | 0 |
| K961487 | ELECSYS HCG ASSAY | Boehringer Mannheim Corp. | 1996-06-12 | 55 | 0 |
| K961351 | HCG ER METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIA | Bayer Corp. | 1996-06-03 | 59 | 0 |
| K955707 | ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT | Excel Scientific, Inc. | 1996-05-02 | 139 | 0 |
| K952283 | AMERLITE HCG-60 ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-17 | 62 | 0 |
| K945331 | AURAFLEX HCG | Organon Teknika Corp. | 1995-03-20 | 139 | 0 |
| K950307 | BIOSTRIP(R) HCG-ONE STEP PREGNANCY TEST | Princeton BioMeditech Corp. | 1995-03-01 | 35 | 0 |
| K941983 | SEALITE SCIENCES INC. | Sealite Sciences, Inc. | 1994-08-18 | 115 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda